Atrial Fibrillation and Ischemic Events With Rivaroxaban in Patients With Stable Coronary Artery Disease - AFIRE

Nov 29, 2021
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Japan Cardiovascular Research Foundation
Date Presented:
11/14/2020
Date Published:
11/01/2021
Date Updated:
11/29/2021
Original Posted Date:
09/02/2019
References

Contribution To Literature:

Highlighted text has been updated as of November 29, 2021.

The AFIRE trial showed that rivaroxaban monotherapy vs. rivaroxaban/antiplatelet therapy was noninferior for ischemia and superior for bleeding with atrial fibrillation and stable coronary artery disease.

Description:

The goal of the trial was to evaluate rivaroxaban monotherapy compared with rivaroxaban/antiplatelet therapy among patients with atrial fibrillation and stable coronary artery disease.

Study Design

  • Randomized
  • Parallel
  • Open-label

Patients with atrial fibrillation and stable coronary artery disease were randomized to rivaroxaban 15 mg daily (10 mg daily for creatine clearance 15-49 ml/min) (n = 1,118) vs. rivaroxaban/antiplatelet therapy (n = 1,118).

  • Total number of enrollees: 2,236
  • Duration of follow-up: 24 months
  • Mean patient age: 74 years
  • Percentage with diabetes: 42%

Inclusion criteria:

  • Patients ≥20 years of age with atrial fibrillation
  • Stable coronary artery disease (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG] ≥1 year prior to enrollment or coronary stenosis ≥50% not requiring revascularization)

Exclusion criteria:

  • Stent thrombosis
  • Active malignancy
  • Poorly controlled hypertension

Other salient features/characteristics:

  • In the combination therapy group, 70% received aspirin, while 27% received a P2Y12 inhibitor as their antiplatelet agent.

Principal Findings:

The trial was terminated early due to excess mortality in the rivaroxaban/antiplatelet therapy group.

The primary efficacy outcome, all-cause mortality, myocardial infarction, stroke, unstable angina requiring revascularization, or systemic embolism, occurred in 4.1%/patient-year of the rivaroxaban monotherapy group compared with 5.8%/patient-year of the rivaroxaban/antiplatelet therapy group (p for noninferiority < 0.0001).

The primary safety outcome, major bleeding (ISTH criteria), occurred in 1.6%/patient-year of the rivaroxaban monotherapy group compared with 2.8%/patient-year of the rivaroxaban/antiplatelet therapy group (p = 0.01).

Secondary outcomes:

  • All-cause death: 1.9%/patient-year of the rivaroxaban monotherapy group compared with 3.4%/patient-year of the rivaroxaban/antiplatelet therapy group (p < 0.05)
  • Cardiovascular death: 1.2%/patient-year of the rivaroxaban monotherapy group compared with 2.0%/patient-year of the rivaroxaban/antiplatelet therapy group (p < 0.05)
  • Primary outcome for rivaroxaban monotherapy versus rivaroxaban/antiplatelet therapy among those who underwent PCI <2 years before enrollment: hazard ratio (HR) 1.29, 95% confidence interval (CI) 0.66-2.50, and among those who underwent PCI ≥2 years before enrollment: HR 0.56, 95% CI 0.37-0.84 (p for interaction = 0.034)
  • Major bleeding for rivaroxaban monotherapy versus rivaroxaban/antiplatelet therapy among those who underwent PCI <2 years before enrollment: HR 0.72, 95% CI 0.30-1.74, and among those who underwent PCI ≥2 years before enrollment: HR 0.48, 95% CI 0.26-0.90 (p for interaction = 0.46)

Interpretation:

Among patients with atrial fibrillation and stable coronary artery disease, rivaroxaban monotherapy vs. rivaroxaban/antiplatelet therapy was noninferior for ischemia and superior for bleeding. To be eligible for this study, patients had to have a history of PCI or CABG ≥1 year prior to enrollment or have non-revascularized coronary disease (≥50% stenosis). For the primary outcome (adverse ischemic events), rivaroxaban monotherapy appeared safer when given to those who had remote PCI (≥2 years prior to enrollment) compared with those who had more recent PCI (1 to <2 years prior to enrollment).

The PIONEER AF-PCI (rivaroxaban), RE-DUAL PCI (dabigatran), and AUGUSTUS (apixaban) trials have all documented the safety of anticoagulation with a novel oral anticoagulant/mono-antiplatelet therapy (so-called “dual therapy”) in the first year after PCI.

The Danish registry, OAC-ALONE, and now this study documented the safety of anticoagulation monotherapy 1 year after PCI.

In summary, several lines of evidence now support that anticoagulation without antiplatelet therapy may be safe in the long-term management of patients with atrial fibrillation and stable coronary artery disease.

References:

Matoba T, Yasuda S, Kaikita K, et al., on behalf of the AFIRE Investigators. Rivaroxaban Monotherapy in Patients With Atrial Fibrillation After Coronary Stenting: Insights From the AFIRE Trial. JACC Cardiovasc Interv 2021;14:2330-40.

Editorial Comment: Faxon DP. Oral Anticoagulant Alone for Patients With AF and a Prior Stent: Is Less Always Best? JACC Cardiovasc Interv 2021;14:2341-3.

Presented by Dr. Tetsuya Matoba at the American Heart Association Virtual Scientific Sessions, November 14, 2020.

Yasuda S, Kaikita K, Akao M, et al., on behalf of the AFIRE Investigators. Antithrombotic Therapy for Atrial Fibrillation With Stable Coronary Disease. N Engl J Med 2019;381:1103-13.

Editorial: Becker RC. Antithrombotic Therapy in Atrial Fibrillation and Coronary Artery Disease. N Engl J Med 2019;381:1169-70.

Presented by Dr. Satoshi Yasuda at the European Society of Cardiology Congress, Paris, France, September 2, 2019.

Clinical Topics: Anticoagulation Management, Arrhythmias and Clinical EP, Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Prevention, Atherosclerotic Disease (CAD/PAD), Anticoagulation Management and Atrial Fibrillation, Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Aortic Surgery, Cardiac Surgery and Arrhythmias, Interventions and Coronary Artery Disease

Keywords: AHA20, AHA Annual Scientific Sessions, ESC Congress, ESC 19, Angina, Unstable, Anticoagulants, Atrial Fibrillation, Arrhythmias, Cardiac, Aspirin, Coronary Artery Bypass, Coronary Artery Disease, Coronary Stenosis, Creatine, Embolism, Myocardial Infarction, Myocardial Ischemia, Percutaneous Coronary Intervention, Platelet Aggregation Inhibitors, Secondary Prevention, Stroke


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